Effect of Different Doses Of Intrathecal Dexmedetomidine In Combination With Bupivacaine On Spinal Anesthesia

NCT07051512 | Completed Phase 1

• 1 other identifier: 36264MS266/7/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the efficacy of different doses of dexmedetomidine in combination with intrathecal hyperbaric bupivacaine on spinal anesthesia and its postoperative analgesic characteristics on patients undergoing infra-umbilical procedures. Primary outcome: To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries Secondary outcomes: Assessment of level of sedation. Assessment of hemodynamic parameters (Blood Pressure -Heart Rate). Assessment of level of sensory \& motor block. Assessment of pain.

Conditions

Spinal Anesthesia Evaluation; Analgesic; Intrathecal Anesthesia

Keywords

Dexmedetomidine; Bupivacaine; Spinal Anesthesia; Postoperative Analgesic; Infra-Umbilical Surgeries

Outcome Measures

Primary Outcomes (2)

• intrathecal dexmedetomidine dose

  To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries.3. The sensory block level will be assessed at 5 min , 20 min after administration of spinal anesthesia and every 15 min postoperative until two segment sensory regression.

  2 hours

• A safe intrathecal dexmedetomidine dose for patients

  To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries

  Intraoperative during 2 hours

Secondary Outcomes (2)

• pain by Visual analogue scale

  24 hours postoperatively.

• intraoperative sedation level using the Ramsay sedation scale

  24 hours post-spinal injection

Study Arms (3)

Group (I):dexmedetomidine 4μg

EXPERIMENTAL

Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

Drug: dexmedetomidine 4μg

Group (II): dexmedetomidine 8 μg

EXPERIMENTAL

Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Drug: dexmedetomidine 8 μg

Group (III): dexmedetomidine 10 μg

EXPERIMENTAL

Group (III): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg

Drug: dexmedetomidine 10 μg

Interventions

dexmedetomidine 4μg DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

Group (I):dexmedetomidine 4μg

dexmedetomidine 8 μg DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Group (II): dexmedetomidine 8 μg

dexmedetomidine 10 μg DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg).

Group (III): dexmedetomidine 10 μg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years of either sex.
• American Society of Anesthesiologists physical status I and II.
• undergoing elective lower abdominal and lower limb surgeries under planned subarachnoid block.

You may not qualify if:

• patient refusal
• contraindication to subarachnoid block (hypersensitivity to the drugs - infection at the site of injection)
• significant comorbid conditions like congestive heart failure, coagulopathy, heart block
• pregnancy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marwa Elakraa, Resident

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All techniques will be performed by one anesthesiologist while the measurements will be taken by another anesthesiologist who is blinded to the study groups and has no subsequent involvement in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

EG (1)